The Recall Desk
ModerateFDA (Devices)·Z-1391-2015·Announced 2015-04-15

Intuitive Surgical Recalls da Vinci Si Camera Arm Drapes

Intuitive Surgical is recalling da Vinci Si Camera Arm Drapes due to a cloudy appearance and potential to tear or transfer waxy substance to patients.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential for physical defect (tearing) and substance transfer without reported injuries or hospitalizations, fitting the Moderate severity criteria.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci Si Surgical System IS3000 Camera Arm Drape, 20 Pack (Product number 420279-03). These drapes are used to cover surgical and non-surgical equipment in clinical settings. The recall involves 442,475 units distributed worldwide to numerous countries, including the United States.

The recall was initiated because the drapes may exhibit a cloudy or waxy appearance. This defect creates a potential for the drape to tear and for a waxy substance to transfer to the patient during use.

Healthcare facilities should stop using the affected drapes and contact Intuitive Surgical for instructions on how to return or dispose of the product. The specific lot numbers affected are listed in the official FDA recall record Z-1391-2015.

The recalled product

Product
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Drapes
Hazard
Affected units
442,475

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Product number 420279-03
  • da Vinci Si Camera Arm Drape
  • 20 Pack. Lot Numbers: D142175
  • D142175A
  • D142185
  • D142185A
  • D142195
  • D142195A
  • D142205
  • D142205A
  • D142215
  • D142215A
  • D142235
  • D142235A
  • D142245
  • D142245A
  • D142255
  • D142255A
  • D142265
  • D142265A

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 14 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

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